Simultaneous determination of acetaminophen, dextromethorphen hydrobromide and pseudoephedrine hydrochloride in a new drug formulation for cold treatment by HPLC

摘要

A rapid and accurate HPLC method is described for the simultaneous determination of acetaminophen, dextromethorphen hydrobromide and pseudoephedrine hydrochloride in a new cold formulation. Chromatographic separation of the three pharmaceuticals was performed on a Hypersil CN column (150×5.0 mm, 5 μm) with a mobile phase mixture of an ion-pairing solution, methanol and acetonitrile (25:57:18, v/v), at a flow rate of 1.0 mL min−1, with detection at 220 nm. Separation was complete in less than 10 min. The method was validated for linearity, accuracy, precision, limit of quantitation and robustness. Linearity, accuracy, and precision were found to be acceptable over the ranges of 2.06∼20.6 μg·mL−1 for acetaminophen, 0.202∼2.02 mg·mL−1 for pseudoephedrine hydrochloride and 0.042∼1.06 mg·mL−1 for dextromethorphen hydrobromide.